- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00049023
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
A Phase I, Open Label, Maximum Tolerated Dose-Finding Study to Evaluate the Safety and Tolerability of 90Y-DOTA-tyr3-Octreotide Administered by Intravenous Infusion to Children With Refractory Somatostatin-Receptor Positive Tumors
RATIONALE: Radiolabeled octreotide can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is to study the safety and effectiveness of radiolabeled octreotide in treating children who have advanced or refractory solid tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90-DOTA-tyr3-octreotide in children with advanced or refractory somatostatin receptor-positive tumors.
- Determine the short-term and long-term safety and the serious adverse-event profiles of this drug in these patients.
- Determine any potential antitumor effect of this drug in these patients.
- Correlate level of somatostatin receptor type 2 expression with response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive yttrium Y 90-DOTA-tyr3-octreotide IV over 5-10 minutes on day 1. Treatment repeats every 6 weeks for up to 3 courses in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of yttrium Y 90-DOTA-tyr3-octreotide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed weekly after each treatment course, 6 weeks after the last course, and then every 6 months thereafter for life.
PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant neoplasm
- Not amenable to standard therapy or has failed existing first- and second-line therapies
- Tumor positive for somatostatin receptors by OctreoScan within the past 4 weeks
At least 1 measurable lesion
- Lesions that have been previously irradiated must demonstrate progression since radiation
- At least 1 measurable somatostatin receptor-positive lesion that has not been irradiated within the past 4 weeks AND has not had full craniospinal radiation within the past 3 months
- Bone marrow with at least 40% cellularity OR at least 20% cellularity with one million CD34+ stem cells/kg stored
- No diffuse bone marrow involvement by OctreoScan scintigraphy
PATIENT CHARACTERISTICS:
Age
- 2 to 25
Performance status
- COG 0-2 OR
- Karnofsky 60-100% OR
- Lansky 60-100%
Life expectancy
- 2-12 months
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 times normal
- AST and ALT less than 2.5 times upper limit of normal
Renal
- Creatinine no greater than 1 mg/dL (children less than 5 years of age)
- Creatinine less than 1.2 mg/dL (children 5 to 10 years of age)
- Creatinine less than 1.7 mg/dL (children over 10 years of age) AND
- Glomerular filtration rate at least 80 mL/min/m^2
Cardiovascular
- Shortening fraction at least 28% by echocardiogram
- Ejection fraction at least 50% by bi-plane method of echocardiogram
- No prior congestive heart failure unless ejection fraction at least 40%
- No unstable angina pectoris
- No cardiac arrhythmia
- No symptomatic congestive heart failure
Other
- No other concurrent malignancy
- No other significant uncontrolled medical, psychiatric, or surgical condition that would preclude study compliance
- No antibodies to yttrium Y 90-DOTA-tyr3-octreotide or octreotide
- No prior allergic reactions to compounds of similar chemical or biologic composition to yttrium Y 90-DOTA-tyr3-octreotide
- No ongoing or active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- More than 28 days since prior long-acting somatostatin analogues
- No concurrent somatostatin analogues 12 hours before or 12 hours after study drug administration
- Concurrent hormonal therapy (other than somatostatin analogue) allowed provided patient received hormonal therapy for at least 2 months and has stable disease or progressive disease
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to 25% or more of bone marrow
- No prior external beam radiotherapy to both kidneys (scatter doses of less than 500 cGy to a single kidney or radiation to less than 50% of a single kidney is allowed)
Surgery
- At least 4 weeks since prior surgery
Other
- Recovered from prior therapy
- At least 4 weeks since prior investigational drugs
- No other concurrent approved or investigational anti-neoplastic therapies except for bisphosphonates
- No concurrent combination antiretroviral therapy for HIV-positive patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 90Y-DOTA-tyr3-OCTREOTIDE
Dose escalation will proceed so that the single-cycle and three-cycle maximum tolerated doses of 90Y-DOTA-tyr3-Octreotide can be determined.
The initial dose of 90Y-DOTA-tyr3-Octreotide to be administered is 30 mCi/m2 in each of three cycles.
Dose escalation will proceed in 10 mCi/m2 intervals and will be permitted for the next cohort of subjects pending completion of Cycle 3 by 2 members of the previous cohort with no DLTs.
A DLT is defined as a Grade 3 renal toxicity, Grade 4 bone marrow toxicity, or any other Grade 3 toxicity whether or not related to study drug and regardless of duration.
Lymphopenia will not be used to define a DLT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide
Time Frame: 6 weeks per cycle
|
Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide administered by intravenous infusion to children with refractory somatostatin-receptor positive tumors based upon the 6 week/cycle dose-limiting-toxicity profile.
|
6 weeks per cycle
|
Evaluate the short term and long term safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events)
Time Frame: short term (6 weeks/cycle); long term (4-6 mos./cycle)
|
2. Evaluate the short-term (6 weeks/cycle) and long term (4-6 months) safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events) serious adverse event profile of three-cycles of 90Y-DOTA-tyr3-Octreotide administered by intravenous infusion to children with refractory somatostatin-receptor positive tumors.
|
short term (6 weeks/cycle); long term (4-6 mos./cycle)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: M. Sue O'Dorisio, MD, PhD, Holden Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- metastatic gastrointestinal carcinoid tumor
- recurrent gastrointestinal carcinoid tumor
- disseminated neuroblastoma
- localized unresectable neuroblastoma
- recurrent neuroblastoma
- regional neuroblastoma
- childhood infratentorial ependymoma
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- regional gastrointestinal carcinoid tumor
- childhood supratentorial ependymoma
- recurrent childhood ependymoma
- recurrent childhood brain tumor
- metastatic pheochromocytoma
- recurrent pheochromocytoma
- recurrent childhood medulloblastoma
- childhood grade III meningioma
- gastrinoma
- insulinoma
- recurrent islet cell carcinoma
- regional pheochromocytoma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Pancreatic Diseases
- Neuroendocrine Tumors
- Neuroectodermal Tumors, Primitive
- Adenoma
- Neuroectodermal Tumors, Primitive, Peripheral
- Pancreatic Neoplasms
- Paraganglioma
- Neoplasms
- Sarcoma
- Gastrointestinal Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neuroblastoma
- Carcinoid Tumor
- Adenoma, Islet Cell
- Malignant Carcinoid Syndrome
- Pheochromocytoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Gastrointestinal Agents
- Antineoplastic Agents, Hormonal
- Radiopharmaceuticals
- Octreotide
- Edotreotide
Other Study ID Numbers
- 200008086
- UIHC-200008086
- NCI-V02-1710
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Centre Oscar LambretFrench Sarcoma Group; Study Group of Bone TumorsCompletedSoft Tissue Sarcoma | Uterine SarcomaFrance
-
David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
Clinical Trials on 90Y-DOTA-tyr3-OCTREOTIDE
-
Sandeep LaroiaNational Cancer Institute (NCI); National Institutes of Health (NIH); Holden...TerminatedNeuroendocrine TumorsUnited States
-
David BushnellNational Cancer Institute (NCI); National Institutes of Health (NIH); Holden...Active, not recruitingNeuroendocrine Tumor Gastrointestinal, Hormone-Secreting | Neuroendocrine Tumor, MalignantUnited States
-
University of IowaNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedNeuroendocrine Tumors | Medulloblastoma | Neuroblastoma | MeningiomaUnited States
-
French Innovative Leukemia OrganisationTerminated
-
European Institute of OncologyCompletedNeuroendocrine TumorsItaly
-
University Hospital, Basel, SwitzerlandCompleted
-
Lale KostakogluTerminatedNeuroendocrine Tumors | Carcinoid TumorsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedMeningioma | Neuroendocrine Neoplasm | Multiple Endocrine Neoplasia Type 1 | Von Hippel-Lindau Syndrome | Metastatic Well Differentiated Neuroendocrine Neoplasm | Somatostatin Positive Neoplastic Cells PresentUnited States
-
Sue O'DorisioNational Cancer Institute (NCI); National Institutes of Health (NIH)WithdrawnMedulloblastoma | Neuroblastoma | Meningioma | Neuroendrocrine Tumors
-
TheradexUnknown